GUEST COLUMNISTS

• Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions

  Life science companies across the world are scrambling to mitigate the impacts of COVID-19 on their clinical studies and business operations, and there are no clear-cut answers at this time, nor a one-size-fits-all solution. But what we do know is that we are all in this together and that this is another challenge that the biotech industry was built for.

• Stand By To Stand By: Organizational Contingency Planning

  The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

   

• COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain

  During crises like this pandemic, bottlenecks in drug distribution and sample testing can be improved through automation, artificial intelligence, and robotics. This article provides an overview of the medical drone industry, with a particular emphasis on its adoption by the pharmaceutical sector to solve logistical problems in healthcare during times of heightened need. 

• EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications

  While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

• What Pharma Can Learn From A Parent Turned Patient Advocate

  I am humbled and honored to introduce you to Andrew McFadyen — founder of the Isaac Foundation. Andrew is a husband, a father, and an advocate who tirelessly works to advance actionable dialogue around access, care, and policy for patients with rare diseases. Recently, I had the opportunity to chat with Andrew about the unique challenges that patients and their families face when dealing with serious illness and how we may better serve their needs.

• Implementing Data Quality By Design For Improved Data Integrity

  We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.

• Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies

  One of the most frequent statements made in the biopharmaceutical industry is the need to “control a product’s critical quality attributes (CQAs) by controlling the process’ critical process parameters (CPPs).” While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.

• Which Biosimilar Companies Will Thrive In 2025?

  Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.